Drug Master File

Optimi Health Secures Amendment to Increase Quantities Of MDMA, MDA, And 2C-B Under Controlled Drugs And Substances Dealer’s Licence

Retrieved on: 
Friday, January 19, 2024

Effectively implemented on January 16, 2024, the amendment allows substantial increases in the quantities of MDMA, MDA, and 2CB under subsection J.01.059(4) of Part J of the Food and Drug Regulations.

Key Points: 
  • Effectively implemented on January 16, 2024, the amendment allows substantial increases in the quantities of MDMA, MDA, and 2CB under subsection J.01.059(4) of Part J of the Food and Drug Regulations.
  • Terms of the amendment now permit the following increases:
    N-METHYL-3,4-METHYLENEDIOXY AMPHETAMINE (MDMA) – from 2kg to 20kg.
  • It enhances our competitive advantage and perfectly aligns with our vision to be the leading global supplier of GMP MDMA and other psychedelic substances."
  • Optimi now has Health Canada approval to manufacture the following controlled substances:

Touchlight’s enzymatic doggybone DNA used in the manufacture of Versameb’s VMB-100 for first-in-human clinical study

Retrieved on: 
Tuesday, November 21, 2023

This FDA clearance represents a further milestone for Touchlight’s enzymatic dbDNA and follows the prior announcement from February 2023 of the first client adopting dbDNA for clinical development in the US.

Key Points: 
  • This FDA clearance represents a further milestone for Touchlight’s enzymatic dbDNA and follows the prior announcement from February 2023 of the first client adopting dbDNA for clinical development in the US.
  • This IND marks the third product to enter clinical development using the dbDNA platform, further demonstrating its regulatory adoption in both the US and Europe.
  • Karen Fallen, CEO, Touchlight commented: “We would like to congratulate Versameb on this achievement and wish them success with their upcoming first-in-human study.
  • dbDNA is uniquely positioned for the rapid, synthetic, and scalable manufacture of GMP DNA using a small, simple footprint.

Creative Medical Technology Holdings Provides Corporate Update

Retrieved on: 
Wednesday, November 15, 2023

PHOENIX, Nov. 15, 2023 /PRNewswire/ -- Creative Medical Technology Holdings, Inc. ("Creative Medical Technology" or the "Company") (NASDAQ: CELZ), a biotechnology company focused on a regenerative approach to immunotherapy, endocrinology, urology, gynecology, and orthopedics, today provided an update on recent business activities in connection with the filing of its Form 10-Q with the Securities and Exchange Commission.  

Key Points: 
  • PHOENIX, Nov. 15, 2023 /PRNewswire/ -- Creative Medical Technology Holdings, Inc. ("Creative Medical Technology" or the "Company") (NASDAQ: CELZ), a biotechnology company focused on a regenerative approach to immunotherapy, endocrinology, urology, gynecology, and orthopedics, today provided an update on recent business activities in connection with the filing of its Form 10-Q with the Securities and Exchange Commission.
  • "We continue to make progress developing our regenerative therapeutics, building important assets, and managing a robust product pipeline, while maintaining a strong financial position," said Timothy Warbington, Chief Executive Officer of Creative Medical Technology.
  • "Our work is supported by a strong intellectual property portfolio consisting of more than 68 patents and patents pending.
  • For the three months ended September 30, 2023 the Company repurchased 40,000 shares of its common stock under the Repurchase Plan.

Purple Biotech Announces Closing of $5 Million Registered Direct Offering

Retrieved on: 
Thursday, October 19, 2023

The gross proceeds to the Company from the offering  are approximately $5 million, before deducting the placement agent’s fees and other offering expenses payable by the Company.

Key Points: 
  • The gross proceeds to the Company from the offering  are approximately $5 million, before deducting the placement agent’s fees and other offering expenses payable by the Company.
  • Purple Biotech intends to use the net proceeds from the offering to fund the development of its oncology therapeutic candidates and for general working capital and corporate purposes.
  • The offering of the ADSs (or ADS equivalents) in the registered direct offering was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.
  • A final prospectus supplement and accompanying prospectus relating to the registered direct offering have been filed with the SEC.

Purple Biotech Announces $5 Million Registered Direct Offering

Retrieved on: 
Tuesday, October 17, 2023

The gross proceeds to the Company from the offering are expected to be approximately $5 million, before deducting the placement agent’s fees and other offering expenses payable by the Company.

Key Points: 
  • The gross proceeds to the Company from the offering are expected to be approximately $5 million, before deducting the placement agent’s fees and other offering expenses payable by the Company.
  • Purple Biotech intends to use the net proceeds from the offering to fund the development of its oncology therapeutic candidates and for general working capital and corporate purposes.
  • The offering of the ADSs (or ADS equivalents) in the registered direct offering is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.
  • A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC.

EQS-News: Eckert & Ziegler and PharmaLogic Sign Reservation Agreement for Supply of Therapeutic Radioisotope Actinium-225

Retrieved on: 
Tuesday, October 17, 2023

Berlin, Germany and BOCA RATON, FL, USA – 10 October 2023 – Eckert & Ziegler (ISIN DE0005659700, SDAX) and PharmaLogic Holdings Corp. (“PharmaLogic”) have signed a reservation agreement for the supply of the therapeutic radioisotope Actinium-225 (Ac-225).

Key Points: 
  • Berlin, Germany and BOCA RATON, FL, USA – 10 October 2023 – Eckert & Ziegler (ISIN DE0005659700, SDAX) and PharmaLogic Holdings Corp. (“PharmaLogic”) have signed a reservation agreement for the supply of the therapeutic radioisotope Actinium-225 (Ac-225).
  • Under the terms of the agreement, PharmaLogic will have access to Eckert & Ziegler's high-purity, non-carrier-added Actinium-225 for the labeling of radiopharmaceuticals for research and development work and commercial use.
  • "The supply of Actinium-225 has been limited for years, slowing both clinical research activities and commercial use,” stated Dr. Harald Hasselmann, CEO of Eckert & Ziegler.
  • "Our agreement with Eckert & Ziegler will ensure our programs can progress efficiently and enable patient access to the latest therapies.”
    Eckert & Ziegler will establish GMP-compliant production of larger quantities of Ac-225 in 2024.

Eckert & Ziegler and PharmaLogic Sign Reservation Agreement for Supply of Therapeutic Radioisotope Actinium-225

Retrieved on: 
Tuesday, October 10, 2023

BERLIN and BOCA RATON, Fla., Oct. 10, 2023 /PRNewswire/ -- Eckert & Ziegler (ISIN DE0005659700, SDAX) and PharmaLogic Holdings Corp. ("PharmaLogic") have signed a reservation agreement for the supply of the therapeutic radioisotope Actinium-225 (Ac-225).

Key Points: 
  • BERLIN and BOCA RATON, Fla., Oct. 10, 2023 /PRNewswire/ -- Eckert & Ziegler (ISIN DE0005659700, SDAX) and PharmaLogic Holdings Corp. ("PharmaLogic") have signed a reservation agreement for the supply of the therapeutic radioisotope Actinium-225 (Ac-225).
  • Under the terms of the agreement, PharmaLogic will have access to Eckert & Ziegler's high-purity, non-carrier-added Actinium-225 for the labeling of radiopharmaceuticals for research and development work and commercial use.
  • "The supply of Actinium-225 has been limited for years, slowing both clinical research activities and commercial use," stated Dr. Harald Hasselmann, CEO of Eckert & Ziegler.
  • "Our agreement with Eckert & Ziegler will ensure our programs can progress efficiently and enable patient access to the latest therapies."

Tonix Pharmaceuticals Announces Pricing of $4.5 Million Public Offering

Retrieved on: 
Friday, September 29, 2023

The closing of the public offering is expected to take place on or about October 3, 2023, subject to the satisfaction of customary closing conditions.

Key Points: 
  • The closing of the public offering is expected to take place on or about October 3, 2023, subject to the satisfaction of customary closing conditions.
  • The gross proceeds of the offering will be approximately $4.5 million before deducting placement agent fees and other estimated offering expenses payable by the Company.
  • Brookline Capital Markets, a division of Arcadia Securities, LLC is acting as co-placement agent for the offering.
  • The offering will be made only by means of a prospectus supplement and accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that Tonix may file with the SEC.

Tonix Pharmaceuticals Announces Proposed Public Offering

Retrieved on: 
Thursday, September 28, 2023

CHATHAM, N.J., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase shares of common stock in a public offering.

Key Points: 
  • CHATHAM, N.J., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase shares of common stock in a public offering.
  • All of the securities to be sold in the offering are to be offered by Tonix.
  • The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
  • Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the public offering, the timing and size of the public offering, the intended use of proceeds from the public offering and other statement that are predictive in nature.

Scinai Immunotherapeutics Announces Closing of $1.33 Million Registered Direct Offering

Retrieved on: 
Tuesday, September 19, 2023

The gross proceeds to the Company from the offering are approximately $1.33 million, before deducting the placement agent’s fees and other offering expenses payable by the Company.

Key Points: 
  • The gross proceeds to the Company from the offering are approximately $1.33 million, before deducting the placement agent’s fees and other offering expenses payable by the Company.
  • The Company intends to use the net proceeds from the offering for general working capital, research and development, and general corporate purposes.
  • The offering of the ADSs (or ADS equivalents) in the registered direct offering was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.
  • A final prospectus supplement and accompanying prospectus relating to the registered direct offering have been filed with the SEC.